[Federal Register Volume 67, Number 47 (Monday, March 11, 2002)]
[Rules and Regulations]
[Pages 11008-11013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5746]



[[Page 11007]]

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Part III





Environmental Protection Agency





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40 CFR Part 721



Perfluoroalkyl Sulfonates; Significant New Use Rule; Final Rule and 
Supplemental Proposed Rule

  Federal Register / Vol. 67, No. 47 / Monday, March 11, 2002 / Rules 
and Regulations  

[[Page 11008]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50639D; FRL-6823-6]
RIN 2070-AD43


Perfluoroalkyl Sulfonates; Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing a significant new use rule (SNUR) under section 
5(a)(2) of the Toxic Substances Control Act (TSCA) for 13 chemicals, 
including polymers, that are derived from perfluorooctanesulfonic acid 
(PFOSH) and its higher and lower homologues. These chemicals are 
collectively referred to as perfluoroalkyl sulfonates, or PFAS. This 
rule requires manufacturers and importers to notify EPA at least 90 
days before commencing the manufacture or import of these chemical 
substances for the significant new uses described in this document. EPA 
believes that this action is necessary because the PFAS component of 
these chemical substances may be hazardous to human health and the 
environment. The required notice will provide EPA with the opportunity 
to evaluate an intended new use and associated activities and, if 
necessary, to prohibit or limit that activity before it occurs. This 
action promulgates a portion of the proposed SNUR originally published 
in the Federal Register of October 18, 2000. This action also removes 
from the SNUR two chemicals that were listed erroneously in that 
original proposal. Published elsewhere in today's issue of the Federal 
Register is a supplemental proposed rule which addresses the remainder 
of the chemicals listed in the original proposed SNUR.

DATES: This final rule is effective on April 10, 2002.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Barbara Cunningham, Acting Director, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 554-1404; e-mail address: [email protected].
    For technical information contact: Mary F. Dominiak, Chemical 
Control Division, (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 564-8104; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture 
(defined by statute to include import) any of the chemical substances 
that are listed in Table 2 of this unit. Persons who intend to import 
any chemical substance governed by a final SNUR are subject to the TSCA 
section 13 (15 U.S.C. 2612) import certification requirements, and to 
the regulations codified at 19 CFR 12.118 through 12.127 and 12.728. 
Those persons must certify that they are in compliance with the SNUR 
requirements. The EPA policy in support of import certification appears 
at 40 CFR part 707, subpart B. In addition, any persons who export or 
intend to export any of the chemical substances listed in Table 2 of 
this unit are subject to the export notification provisions of TSCA 
section 12(b) (15 U.S.C. 2611(b)), and must comply with the export 
notification requirements in 40 CFR 721.20 and 40 CFR part 707, subpart 
D. Potentially affected categories and entities may include, but are 
not limited to:

                 Table 1.--Potentially Affected Entities
------------------------------------------------------------------------
                                                        Examples of
          Categories               NAICS codes      potentially affected
                                                          entities
------------------------------------------------------------------------
Chemical Manufacturers or       325                Persons who
 Importers                                          manufacture (defined
                                                    by statute to
                                                    include import) one
                                                    or more of the
                                                    subject chemical
                                                    substances
------------------------------------------------------------------------
Chemical Exporters              325                Persons who export,
                                                    or intend to export,
                                                    one or more of the
                                                    subject chemical
                                                    substances
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table in this unit 
could also be affected. The North American Industrial Classification 
System (NAICS) codes have been provided to assist you and others in 
determining whether or not this action applies to certain entities. To 
determine whether you or your business is affected by this action, you 
should carefully examine the applicability provisions in 40 CFR 721.5 
for SNUR-related obligations. Also, consult Unit II. Note that because 
this rule designates certain manufacturing and importing activities as 
significant new uses, persons that solely process existing stocks of 
the chemical substances that are covered by this action would not be 
subject to the rule. If you have any questions regarding the 
applicability of this action to a particular entity, consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.
    One chemical in Table 2 of this unit is identified by both 
premanufacture notice (PMN) and Chemical Abstract Service number (CAS 
No.). In the proposed SNUR, only the PMN appeared with the chemical.


        Table 2.--Chemical Substances Covered by this Final Rule
------------------------------------------------------------------------
            CAS No./PMN                CAS Ninth Collective Index Name
------------------------------------------------------------------------
2250-98-8                           1-Octanesulfonamide, N,N',N''-
                                     [phosphinylidynetris(oxy-2,1-
                                     ethanediyl)]tris[N-ethyl-
                                     1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                     heptadecafluoro-
------------------------------------------------------------------------
30381-98-7                          1-Octanesulfonamide, N,N'-
                                     [phosphinicobis(oxy-2,1-
                                     ethanediyl)]bis[N-ethyl-
                                     1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                     heptadecafluoro-, ammonium salt
------------------------------------------------------------------------

[[Page 11009]]

 
57589-85-2                          Benzoic acid, 2,3,4,5-tetrachloro-6-
                                     [[[3-
                                     [[(heptadecafluorooctyl)sulfonyl]ox
                                     y]phenyl]amino]carbonyl]-,
                                     monopotassium salt
------------------------------------------------------------------------
61660-12-6                          1-Octanesulfonamide, N-ethyl-
                                     1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                     heptadecafluoro-N-[3-
                                     (trimethoxysilyl)propyl]-
------------------------------------------------------------------------
67969-69-1                          1-Octanesulfonamide, N-ethyl-
                                     1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                     heptadecafluoro-N-[2-
                                     (phosphonooxy)ethyl]-, diammonium
                                     salt
------------------------------------------------------------------------
68608-14-0                          Sulfonamides, C4-8-alkane,
                                     perfluoro, N-ethyl-N-
                                     (hydroxyethyl), reaction products
                                     with 1,1'-methylenebis[4-
                                     isocyanatobenzene]
------------------------------------------------------------------------
70776-36-2                          2-Propenoic acid, 2-methyl-,
                                     octadecyl ester, polymer with 1,1-
                                     dichloroethene, 2-
                                     [[(heptadecafluorooctyl)sulfonyl]me
                                     thylamino]ethyl 2-propenoate, N-
                                     (hydroxymethyl)-2-propenamide, 2-
                                     [methyl[(nonafluorobutyl)sulfonyl]a
                                     mino]ethyl 2-propenoate, 2-
                                     [methyl[(pentadecafluoroheptyl)sulf
                                     onyl]amino]ethyl 2-propenoate, 2-
                                     [methyl[(tridecafluorohexyl)sulfony
                                     l]amino]ethyl 2-propenoate and 2-
                                     [methyl[(undecafluoropentyl)sulfony
                                     l]amino]ethyl 2-propenoate
------------------------------------------------------------------------
127133-66-8                         2-Propenoic acid, 2-methyl-,
                                     polymers with Bu methacrylate,
                                     lauryl methacrylate and 2-
                                     [methyl[(perfluoro-C4-8-
                                     alkyl)sulfonyl]amino]ethyl
                                     methacrylate
------------------------------------------------------------------------
148240-78-2                         Fatty acids, C18-unsatd., trimers, 2-
                                     [[(heptadecafluorooctyl)sulfonyl]me
                                     thylamino]ethyl esters
------------------------------------------------------------------------
148684-79-1                         Sulfonamides, C4-8-alkane,
                                     perfluoro, N-(hydroxyethyl)-N-
                                     methyl, reaction products with 1,6-
                                     diisocyanatohexane homopolymer and
                                     ethylene glycol
------------------------------------------------------------------------
178535-22-3                         Sulfonamides, C4-8-alkane,
                                     perfluoro, N-ethyl-N-(hydroxyethyl)-
                                     , polymers with 1,1'-methylenebis[4-
                                     isocyanatobenzene] and
                                     polymethylenepolyphenylene
                                     isocyanate, 2-ethylhexyl esters, Me
                                     Et ketone oxime-blocked
------------------------------------------------------------------------
P-94-2205                           Polymethylenepolyphenylene
                                     isocyanate and bis(4-NCO-
                                     phenyl)methane reaction products
                                     with 2-ethyl-1-hexanol, 2-butanone,
                                     oxime, N-ethyl-N-(2- hydroxyethyl)-
                                     1-C4-C8 perfluoroalkanesulfonamide
------------------------------------------------------------------------
P-96-1645                           Fatty acids, C18-unsatd., dimers, 2-
306974-63-0.......................   [methyl[(perfluoro-C4-8-
                                     alkyl)sulfonyl]amino]ethyl esters
------------------------------------------------------------------------


B. How Can I Get Additional Information, Including Copies of this 
Document or Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPPTS-50639D. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as Confidential Business Information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period, is available 
for inspection in the TSCA Nonconfidential Information Center, North 
East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. 
The Center is open from noon to 4 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Center is (202) 
260-7099.

II. Background

A. What Action is the Agency Taking?

    This rule requires persons to notify EPA at least 90 days before 
commencing the manufacture or import of the chemical substances 
identified in Table 2, Unit I.A., for the significant new use described 
in this document. The chemical substances identified in Table 2, Unit 
I.A., are 13 chemical substances, including polymers, that are derived 
from PFOSH and its homologues. These chemical substances are 
collectively referred to throughout this rule as PFAS. In the original 
proposed SNUR, these chemicals had been referred to collectively as 
perfluorooctyl sulfonates, or PFOS, but commenters noted that this 
generic usage of the term PFOS was inconsistent with the use by the 
manufacturer, the Minnesota Mining and Manufacturing Company (3M), of 
PFOS to refer only to chemicals with an eight-carbon, or C8, chain 
length. Many of the chemicals in the SNUR include a range of carbon 
chain lengths, although they all include C8 within the range. 
Accordingly, EPA will use the generic term PFAS to refer to any carbon 
chain length, including higher and lower homologues as well as C8, and 
the term PFOS to represent only those chemical substances which are 
predominantly C8.
    The significant new use described by this document is: The 
manufacture or import for any use of any of the chemicals listed in 
Table 2, Unit I.A., on or after January 1, 2001.
    The chemical substances subject to this SNUR are listed in Table 2, 
Unit I.A. All of these chemical substances have the potential to 
degrade to PFOSH in the environment. Information also suggests that 
these chemical substances may be converted to PFOSH via incomplete 
oxidation during the

[[Page 11010]]

incineration of PFOS-containing materials. Once PFOSH has been released 
to the environment, it does not undergo further chemical (hydrolysis), 
microbial, or photolytic degradation. PFOS is highly persistent in the 
environment and has a strong tendency to bioaccumulate. Studies have 
found PFOS in very small quantities in the blood of the general human 
population as well as in wildlife, indicating that exposure to the 
chemicals is widespread, and recent tests have raised concerns about 
their potential developmental, reproductive, and systemic toxicity 
(Refs. 1, 2, and 3). These facts, taken together, raise concerns for 
long term potential adverse effects in people and wildlife over time if 
PFOS should continue to be produced, released, and built up in the 
environment.
    Based on all information available to EPA, including the comments 
filed on the proposed SNUR published in the Federal Register of October 
18, 2000 (65 FR 62319) (FRL-6745-5), EPA believes that the chemical 
substances listed in Table 2, Unit I.A., were manufactured and imported 
in the United States only by 3M (Refs. 4 and 5). 3M committed to phase 
out these chemicals voluntarily by discontinuing their manufacture on a 
global basis by the end of December 2000, and 3M has confirmed that 
these chemicals were discontinued on schedule (Refs. 6 and 7). EPA 
believes that any manufacture or import for any use of these specific 
PFAS chemicals occurring after 3M's phase-out would thus be new. All 
manufactured PFAS has the potential to contribute to the globally 
available reservoir of PFAS that has resulted in the detectable levels 
of PFOS in the general population and wildlife. Any new manufacture or 
import of the PFAS chemicals listed in this rule, particularly for 
their historical, high volume uses, would significantly increase the 
magnitude and duration of exposure to these chemicals by adding to the 
existing burden of PFOS in the environment.
    The chemical substances listed in Table 2, Unit I.A., were 
principally associated with uses in carpet, fabric, leather, textile, 
and paper coatings. None of the comments received on the proposed SNUR 
addressed any of these uses or focused on these particular substances. 
Although certain initial comments filed on the proposed SNUR sought 
blanket exemptions for specific uses of any chemical substances listed 
in the proposed SNUR, including the ones covered by this final rule, 
subsequent clarifications and additional correspondence submitted to 
the docket by the commenters indicated that none of the chemical 
substances listed in Table 2, Unit I.A., were or are being manufactured 
for, imported, or used in any of the specific uses for which they 
sought an exemption.
    This action also removes from the original proposed SNUR two 
chemicals which were not included in the 3M phaseout plan. These two 
chemicals (CAS No. 148240-79-3 and CAS No. 148240-81-7) were listed in 
the originally proposed SNUR due to an error by EPA in correlating 
information provided by 3M with chemical identity data furnished by the 
Chemical Abstract Service. Comments submitted by 3M pointed out this 
error. EPA acknowledges that, because these two chemicals were not 
included in the 3M phaseout plan, they should not have been included in 
the original proposed SNUR. Accordingly, these two chemicals are not 
subject to any current proposed or final SNUR, and thus would not be 
subject to any corresponding SNUR-related reporting obligations.
    Other chemicals originally included in the two tables in the 
proposed SNUR are addressed separately in a supplemental proposed SNUR 
published elsewhere in today's issue of the Federal Register. This 
final rule applies only to the specific chemical substances listed in 
Table 2, Unit I.A., on which no comments were received.

B. What is the Agency's Authority for Taking this Action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' The Agency makes this determination by rule after considering 
all relevant factors, including those listed in TSCA section 5(a)(2). 
These factors include the volume of a chemical substance's production; 
the extent to which a use changes the type, form, magnitude, or 
duration of exposure to the substance; and the reasonably anticipated 
manner of producing or otherwise managing the substance. Once EPA makes 
this determination and promulgates a SNUR, TSCA section 5(a)(1)(B) 
requires persons to submit a significant new use notice (SNUN) to EPA 
at least 90 days before they manufacture, import, or process the 
chemical substance for that significant new use (15 U.S.C. 2604 
(a)(1)(B)).
    With respect to the chemical substances listed in Table 2, Unit 
I.A., all production had ceased on or before December 31, 2000, as 
discussed in Unit II.A. Any new manufacture or import for any use 
following that date would thus significantly change the volume of 
production, which was zero. By adding to the base amount of PFOS 
already detected in the environment around the world, any new 
manufacture or import for any use of these substances would also change 
the magnitude and duration of exposure to PFOS, because PFOS has been 
found to be both persistent and bioaccumulative. No comments submitted 
on the proposed SNUR suggested that these specific substances might be 
produced or managed any differently than they were in the past if they 
were to be produced again, particularly for their former uses, leading 
to the reasonable inference that any new manufacture or importation of 
these substances for any use would present hazard, exposure, and 
release concerns similar to those which prompted the promulgation of 
this SNUR. Accordingly, pursuant to TSCA section 5(a)(1)(B), EPA 
requires persons to submit a SNUN to EPA at least 90 days before they 
manufacture or import the chemical substances listed in Table 2 for any 
use (15 U.S.C. 2604 (a)(1)(B)).
    As noted in the proposed SNUR, EPA believes that the intent of TSCA 
section 5(a)(1)(B) is best served by designating a use as a significant 
new use as of the proposal date of the SNUR, rather than as of the 
effective date of the final rule. If uses begun after publication of 
the proposed SNUR were considered to be ongoing, rather than new, it 
would be difficult for EPA to establish SNUR notice requirements, 
because any person could defeat the SNUR by initiating the proposed 
significant new use before the rule became final, and then argue that 
the use was ongoing.
    Accordingly, persons who may have begun commercial manufacture or 
import of the PFAS chemicals listed in Table 2, Unit I.A., for the 
significant new uses listed in this final SNUR after the proposal was 
published on October 18, 2000, must stop that activity before the 
effective date of this final rule. Persons who ceased those activities 
will have to meet all SNUR notice requirements and wait until the end 
of the notice review period, including all extensions, before engaging 
in any activities designated as significant new uses. If, however, 
persons who may have begun commercial manufacture or import of these 
chemical substances between the proposal and the effective date of the 
SNUR meet the conditions of advance compliance as codified at 40 CFR 
721.45(h), those persons will be considered to have met the final SNUR 
requirements for those activities.

III. References

    These references have been placed in the official record that was 
established under docket control number OPPTS-

[[Page 11011]]

50639 for this rulemaking as indicated in Unit I.B.2. Reference 
documents identified with an Administrative Record number (AR) are 
cross-indexed to non-regulatory, publicly accessible information files 
maintained in the TSCA Nonconfidential Information Center. Copies of 
these documents can be obtained as described in Unit I.B.2.
    1. (AR226-0620) Sulfonated Perfluorochemicals in the Environment: 
Sources, Dispersion, Fate, and Effects. 3M. St. Paul, MN. March 1, 
2000.
    2. (AR226-0547) The Science of Organic Fluorochemistry. 3M. St. 
Paul, MN. February 5, 1999.
    3. (AR226-0548) Perfluorooctane Sulfonate: Current Summary of Human 
Sera, Health and Toxicology Data. 3M. St. Paul, MN. January 21, 1999.
    4. (AR226-0550) Fluorochemical Use, Distribution, and Release 
Overview. 3M. St. Paul, MN. May 26, 1999.
    5. Rice, Cody. Domestic Manufacturers or Importers of PFOS 
Chemicals Other Than 3M. USEPA/OPPT/EETD. Washington, DC. August 31, 
2000.
    6. (AR226-0600) Weppner, William A. Phase-out Plan for POSF-Based 
Products. 3M. St. Paul, MN. July 7, 2000.
    7. (AR226-0997) Santoro, Mike. E-mail to Charles Auer, Production 
of PFOS Derivatives. 3M. St. Paul, MN. March 2, 2001.

IV. Regulatory Assessment Requirements

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), the Office of Management and 
Budget (OMB) has determined that SNURs are not a ``significant 
regulatory action'' subject to review by OMB, because SNURs do not meet 
the criteria in section 3(f) of the Executive order.
    Based on EPA's experience with past SNURs, State, local, and tribal 
governments have not been impacted by these rules, and EPA does not 
have any reasons to believe that any State, local, or tribal government 
will be impacted by this rule. As such, EPA has determined that this 
regulatory action does not impose any enforceable duty, contain any 
unfunded mandate, or otherwise have any effect on small governments 
subject to the requirements of sections 202, 203, 204, or 205 of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
    This rule does not have tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This does 
not significantly or uniquely affect the communities of Indian tribal 
governments, nor does it involve or impose any requirements that affect 
Indian Tribes. Accordingly, the requirements of section 3(b) of 
Executive Order 13084, entitled Consultation and Coordination with 
Indian Tribal Governments (63 FR 276755, May 19, 1998), do not apply to 
this rule. Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000), which took effect on January 6, 2001, revokes Executive Order 
13084 as of that date. EPA developed this rulemaking, however, during 
the period when Executive Order 13084 was in effect; thus, EPA 
addressed tribal considerations under Executive Order 13084. For the 
same reasons stated for Executive Order 13084, the requirements of 
Executive Order 13175 do not apply to this rule either. Nor will this 
action have a substantial direct effect on States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999).
    This rule is not subject to Executive Order 13211, entitled Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001), because this action 
is not expected to affect energy supply, distribution, or use.
    In issuing this rule, EPA has taken the necessary steps to 
eliminate drafting errors and ambiguity, minimize potential litigation, 
and provide a clear legal standard for affected conduct, as required by 
section 3 of Executive Order 12988, entitled Civil Justice Reform (61 
FR 4729, February 7, 1996).
    EPA has complied with Executive Order 12630, entitled Governmental 
Actions and Interference with Constitutionally Protected Property 
Rights (53 FR 8859, March 15, 1988), by examining the takings 
implications of this rule in accordance with the ``Attorney General's 
Supplemental Guidelines for the Evaluation of Risk and Avoidance of 
Unanticipated Takings'' issued under the Executive Order.
    This action does not involve special considerations of 
environmental justice related issues as required by Executive Order 
12898, entitled Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations (59 FR 7629, February 
16, 1994).
    This action is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866, and 
this action does not address environmental health or safety risks 
disproportionately affecting children.
    In addition, since this action does not involve any technical 
standards, section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 
U.S.C. 272 note), does not apply to this action.
    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of this SNUR will not have a significant adverse economic impact on a 
substantial number of small entities. A SNUR applies to any person 
(including small or large entities) who intends to engage in any 
activity described in the rule as a ``significant new use.'' By 
definition of the word ``new,'' and based on all information currently 
available to EPA, it appears that no small or large entities currently 
engage in such activity. Since a SNUR requires merely that any person 
who intends to engage in such activity in the future must first notify 
EPA (by submitting a SNUN), no economic impact will even occur until 
someone decides to engage in those activities. As a voluntary action, 
it is reasonable to presume that this decision would be based on a 
determination by the person submitting the SNUN that the potential 
benefits would outweigh the costs. Although some small entities may 
decide to conduct such activities in the future, EPA cannot presently 
determine how many, if any, there may be. EPA's experience to date is 
that, in response to the promulgation of over 530 SNURs, the Agency has 
received fewer than 15 SNUNs. Of those SNUNs submitted, none appear to 
be from small entities. In fact, EPA expects to receive few, if any, 
SNUNs from either large or small entities in response to any SNUR. 
Therefore, EPA believes that the economic impact of complying with a 
SNUR is not expected to be significant or adversely impact a 
substantial number of small entities. This rationale has been provided 
to the Chief Counsel for Advocacy of the Small Business Administration.
    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., an agency may not conduct or sponsor, and a person is not 
required to respond to a collection of information that requires OMB 
approval under the

[[Page 11012]]

PRA, unless it has been approved by OMB and displays a currently valid 
OMB control number. The OMB control numbers for EPA's regulations, 
after initial display in the Federal Register and in addition to its 
display on any related collection instrument, are listed in 40 CFR part 
9.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to the PRA under OMB control 
number 2070-0038 (EPA ICR No. 1188.06). This action does not impose any 
burden requiring additional OMB approval. If an entity were to submit a 
SNUN to the Agency, the annual burden is estimated to average between 
98.96 and 118.92 hours per response at an estimated reporting cost of 
between $5,957 and $7,192 per SNUN. This burden estimate includes the 
time needed to review instructions, search existing data sources, 
gather and maintain the data needed, and complete, review and submit 
the required SNUN, and maintain the required records. This burden 
estimate does not include 1 hour of technical time at $64.30 per hour 
estimated to be required for customer notification of SNUR 
requirements, or the $2,500 user fee for submission of a SNUN ($100 for 
businesses with less than $40 million in annual sales).
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques to the Director, 
Collection Strategies Division, Office of Environmental Information, 
Environmental Protection Agency (2822), 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. Please remember to include the OMB control number 
in any correspondence, but do not submit any completed forms to this 
address.

V. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and the Comptroller General of the United 
States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous materials, Reporting 
and recordkeeping requirements, Significant new uses.


    Dated: March 4, 2002.
William H. Sanders, III,
Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR chapter I is amended as follows:

PART 721--[AMENDED]

    1. The authority citation for part 721 continues to read as 
follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).


    2. By adding new Sec. 721.9582 to subpart E to read as follows:


Sec. 721.9582  Certain perfluoroalkyl sulfonates.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances listed in Table 1 of this 
paragraph are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.


  Table 1.--PFAS Chemicals Subject to Reporting on or After January 1,
                                  2001
------------------------------------------------------------------------
            CAS No./PMN                CAS Ninth Collective Index Name
------------------------------------------------------------------------
2250-98-8                           1-Octanesulfonamide, N,N',N''-
                                     [phosphinylidynetris(oxy-2,1-
                                     ethanediyl)]tris[N-ethyl-
                                     1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                     heptadecafluoro-
------------------------------------------------------------------------
30381-98-7                          1-Octanesulfonamide, N,N'-
                                     [phosphinicobis(oxy-2,1-
                                     ethanediyl)]bis[N-ethyl-
                                     1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                     heptadecafluoro-, ammonium salt
------------------------------------------------------------------------
57589-85-2                          Benzoic acid, 2,3,4,5-tetrachloro-6-
                                     [[[3-
                                     [[(heptadecafluorooctyl)sulfonyl]ox
                                     y]phenyl]amino]carbonyl]-,
                                     monopotassium salt
------------------------------------------------------------------------
61660-12-6                          1-Octanesulfonamide, N-ethyl-
                                     1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                     heptadecafluoro-N-[3-
                                     (trimethoxysilyl)propyl]-
------------------------------------------------------------------------
67969-69-1                          1-Octanesulfonamide, N-ethyl-
                                     1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                     heptadecafluoro-N-[2-
                                     (phosphonooxy)ethyl]-, diammonium
                                     salt
------------------------------------------------------------------------
68608-14-0                          Sulfonamides, C4-8-alkane,
                                     perfluoro, N-ethyl-N-
                                     (hydroxyethyl), reaction products
                                     with 1,1'-methylenebis[4-
                                     isocyanatobenzene]
------------------------------------------------------------------------
70776-36-2                          2-Propenoic acid, 2-methyl-,
                                     octadecyl ester, polymer with 1,1-
                                     dichloroethene, 2-
                                     [[(heptadecafluorooctyl)sulfonyl]me
                                     thylamino]ethyl 2-propenoate, N-
                                     (hydroxymethyl)-2-propenamide, 2-
                                     [methyl[(nonafluorobutyl)sulfonyl]a
                                     mino]ethyl 2-propenoate, 2-
                                     [methyl[(pentadecafluoroheptyl)sulf
                                     onyl]amino]ethyl 2-propenoate, 2-
                                     [methyl[(tridecafluorohexyl)sulfony
                                     l]amino]ethyl 2-propenoate and 2-
                                     [methyl[(undecafluoropentyl)sulfony
                                     l]amino]ethyl 2-propenoate
------------------------------------------------------------------------
127133-66-8                         2-Propenoic acid, 2-methyl-,
                                     polymers with Bu methacrylate,
                                     lauryl methacrylate and 2-
                                     [methyl[(perfluoro-C4-8-
                                     alkyl)sulfonyl]amino]ethyl
                                     methacrylate
------------------------------------------------------------------------
148240-78-2                         Fatty acids, C18-unsatd., trimers, 2-
                                     [[(heptadecafluorooctyl)sulfonyl]me
                                     thylamino]ethyl esters
------------------------------------------------------------------------
148684-79-1                         Sulfonamides, C4-8-alkane,
                                     perfluoro, N-(hydroxyethyl)-N-
                                     methyl, reaction products with 1,6-
                                     diisocyanatohexane homopolymer and
                                     ethylene glycol
------------------------------------------------------------------------

[[Page 11013]]

 
178535-22-3                         Sulfonamides, C4-8-alkane,
                                     perfluoro, N-ethyl-N-(hydroxyethyl)-
                                     , polymers with 1,1'-methylenebis[4-
                                     isocyanatobenzene] and
                                     polymethylenepolyphenylene
                                     isocyanate, 2-ethylhexyl esters, Me
                                     Et ketone oxime-blocked
------------------------------------------------------------------------
P-94-2205                           Polymethylenepolyphenylene
                                     isocyanate and bis(4-NCO-
                                     phenyl)methane reaction products
                                     with 2-ethyl-1-hexanol, 2-butanone,
                                     oxime, N-ethyl-N-(2- hydroxyethyl)-
                                     1-C4-C8 perfluoroalkanesulfonamide
------------------------------------------------------------------------
P-96-1645                           Fatty acids, C18-unsatd., dimers, 2-
306974-63-0.......................   [methyl[(perfluoro-C4-8-
                                     alkyl)sulfonyl]amino]ethyl esters
------------------------------------------------------------------------


    (2) The significant new uses are:
    (i) Any manufacture or import for any use of any chemical listed in 
Table 1 of paragraph (a)(1) of this section on or after January 1, 
2001.
    (ii) [Reserved]
    (b) [Reserved]

[FR Doc. 02-5746 Filed 3-8-02; 8:45 am]
BILLING CODE 6560-50-S